Trial Outcomes & Findings for Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. (NCT NCT02460224)
NCT ID: NCT02460224
Last Updated: 2022-02-10
Results Overview
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
490 participants
Primary outcome timeframe
15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
Results posted on
2022-02-10
Participant Flow
Participants took part in 25 investigative sites in 12 countries.
The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 21 days before Cycle 1 Day 1, except for baseline radiological evaluations which had to be done within 28 days.
Participant milestones
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
|
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
6
|
6
|
6
|
30
|
30
|
5
|
6
|
11
|
5
|
6
|
6
|
6
|
5
|
6
|
20
|
6
|
12
|
7
|
6
|
12
|
6
|
11
|
6
|
6
|
121
|
21
|
93
|
|
Overall Study
Rest of the World Patients in the Dose Escalation Part
|
13
|
12
|
6
|
6
|
6
|
25
|
24
|
5
|
6
|
11
|
5
|
6
|
6
|
6
|
5
|
6
|
20
|
6
|
12
|
7
|
6
|
12
|
6
|
11
|
6
|
6
|
0
|
0
|
0
|
|
Overall Study
Japanese Patients in the Dose Escalation Part
|
4
|
0
|
0
|
0
|
0
|
5
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
12
|
6
|
6
|
6
|
30
|
30
|
5
|
6
|
11
|
5
|
6
|
6
|
6
|
5
|
6
|
20
|
6
|
12
|
7
|
6
|
12
|
6
|
11
|
6
|
6
|
121
|
21
|
93
|
Reasons for withdrawal
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
|
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
11
|
1
|
6
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
1
|
5
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
1
|
1
|
2
|
1
|
1
|
0
|
0
|
1
|
0
|
14
|
1
|
6
|
|
Overall Study
Progressive disease
|
15
|
11
|
5
|
6
|
3
|
26
|
28
|
4
|
5
|
9
|
5
|
4
|
5
|
4
|
5
|
5
|
15
|
3
|
8
|
3
|
4
|
9
|
4
|
11
|
4
|
5
|
85
|
17
|
77
|
|
Overall Study
Subject/guardian decision
|
2
|
0
|
1
|
0
|
2
|
2
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
6
|
2
|
3
|
Baseline Characteristics
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
Baseline characteristics by cohort
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=121 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
n=21 Participants
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
|
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=93 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
|
Total
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 12.55 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 12.43 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 20.76 • n=4 Participants
|
61.2 years
STANDARD_DEVIATION 9.58 • n=21 Participants
|
57.2 years
STANDARD_DEVIATION 10.94 • n=8 Participants
|
56.7 years
STANDARD_DEVIATION 10.82 • n=8 Participants
|
60.8 years
STANDARD_DEVIATION 9.36 • n=24 Participants
|
54.8 years
STANDARD_DEVIATION 17.26 • n=42 Participants
|
59.5 years
STANDARD_DEVIATION 7.16 • n=42 Participants
|
60.4 years
STANDARD_DEVIATION 7.16 • n=42 Participants
|
54.3 years
STANDARD_DEVIATION 8.78 • n=42 Participants
|
58.0 years
STANDARD_DEVIATION 5.90 • n=36 Participants
|
44.8 years
STANDARD_DEVIATION 5.23 • n=36 Participants
|
58.2 years
STANDARD_DEVIATION 10.03 • n=24 Participants
|
48.7 years
STANDARD_DEVIATION 24.36 • n=135 Participants
|
59.1 years
STANDARD_DEVIATION 12.83 • n=136 Participants
|
61.2 years
STANDARD_DEVIATION 11.34 • n=44 Participants
|
61.3 years
STANDARD_DEVIATION 8.25 • n=667 Participants
|
51.1 years
STANDARD_DEVIATION 12.03 • n=12 Participants
|
59.8 years
STANDARD_DEVIATION 8.11 • n=12 Participants
|
51.8 years
STANDARD_DEVIATION 12.10 • n=12 Participants
|
59.2 years
STANDARD_DEVIATION 5.42 • n=12 Participants
|
56.6 years
STANDARD_DEVIATION 10.31 • n=11 Participants
|
60.7 years
STANDARD_DEVIATION 6.89 • n=6 Participants
|
52.3 years
STANDARD_DEVIATION 12.50 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 10.79 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 8.94 • n=408 Participants
|
58.4 years
STANDARD_DEVIATION 11.18 • n=206 Participants
|
58.1 years
STANDARD_DEVIATION 11.49 • n=16 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
53 Participants
n=7 Participants
|
20 Participants
n=408 Participants
|
40 Participants
n=206 Participants
|
248 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
11 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
68 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
53 Participants
n=206 Participants
|
242 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
7 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
69 Participants
n=7 Participants
|
15 Participants
n=408 Participants
|
70 Participants
n=206 Participants
|
347 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
48 Participants
n=7 Participants
|
4 Participants
n=408 Participants
|
17 Participants
n=206 Participants
|
122 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 armsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms. Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=16 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=5 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=28 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=27 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=17 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=4 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=9 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=5 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Non-small cell lung cancer (NSCLC)
|
15.0 percentage of participants
Interval 4.2 to 34.4
|
—
|
0 percentage of participants
Interval 0.0 to 12.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Melanoma
|
15.0 percentage of participants
Interval 4.2 to 34.4
|
—
|
9.1 percentage of participants
Interval 1.6 to 25.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Renal cell cancer (RCC)
|
26.3 percentage of participants
Interval 11.0 to 47.6
|
—
|
5.3 percentage of participants
Interval 0.3 to 22.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Mesothelioma
|
17.1 percentage of participants
Interval 8.3 to 29.7
|
—
|
6.3 percentage of participants
Interval 0.3 to 26.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Triple negative breast cancer (TNBC)
|
14.3 percentage of participants
Interval 4.0 to 32.9
|
4.8 percentage of participants
Interval 0.2 to 20.7
|
0 percentage of participants
Interval 0.0 to 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, ROW patients
|
13 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
24 Participants
|
24 Participants
|
5 Participants
|
6 Participants
|
11 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
19 Participants
|
6 Participants
|
12 Participants
|
7 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, ROW patients
|
4 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
11 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, Japanese patients
|
4 Participants
|
—
|
—
|
—
|
—
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, Japanese patients
|
0 Participants
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, Non-small cell lung cancer (NSCLC)
|
19 Participants
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, Non-small cell lung cancer (NSCLC)
|
13 Participants
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, Melanoma
|
19 Participants
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, Melanoma
|
8 Participants
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, Renal cell cancer (RCC)
|
19 Participants
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, Renal cell cancer (RCC)
|
14 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, Mesothelioma
|
41 Participants
|
—
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, Mesothelioma
|
15 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, Triple negative breast cancer (TNBC)
|
21 Participants
|
21 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs, Triple negative breast cancer (TNBC)
|
9 Participants
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 4.4 years.Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, ROW patients
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, ROW patients
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose reduction, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose interruption, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, Japanese patients
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, Japanese patients
|
0 Participants
|
—
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 2.6 years.Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, NSCLC patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, NSCLC patients
|
3 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose reduction, NSCLC patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose interruption, NSCLC patients
|
3 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, melanoma patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, melanoma patients
|
4 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose reduction, melanoma patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose interruption, melanoma patients
|
4 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, RCC patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, RCC patients
|
5 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose reduction, RCC patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose interruption, RCC patients
|
5 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, mesothelioma patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, mesothelioma patients
|
8 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose reduction, mesothelioma patients
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose interruption, mesothelioma patients
|
8 Participants
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose reduction, TNBC patients
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
LAG525 dose interruption, TNBC patients
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose reduction, TNBC patients
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
PDR001 dose interruption, TNBC patients
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 4.4 years.Population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, ROW patients
|
98.9 percentage
Standard Deviation 3.93
|
100 percentage
Standard Deviation 0
|
94.4 percentage
Standard Deviation 13.61
|
100 percentage
Standard Deviation 0
|
98.2 percentage
Standard Deviation 4.47
|
99.0 percentage
Standard Deviation 5.00
|
99.9 percentage
Standard Deviation 0.60
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
97.4 percentage
Standard Deviation 6.27
|
100 percentage
Standard Deviation 0
|
99.7 percentage
Standard Deviation 0.84
|
100 percentage
Standard Deviation 0
|
99.6 percentage
Standard Deviation 0.93
|
97.8 percentage
Standard Deviation 5.27
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
97.7 percentage
Standard Deviation 7.54
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
|
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
PDR001, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
97.3 percentage
Standard Deviation 6.72
|
100 percentage
Standard Deviation 0
|
97.6 percentage
Standard Deviation 5.00
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
98.0 percentage
Standard Deviation 4.95
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
|
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, Japanese patients
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
98.0 percentage
Standard Deviation 4.47
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 2.6 years.Population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). The RDI of both study drugs is reported for each tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, NSCLC patients
|
100 percentage
Standard Deviation 0
|
—
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
PDR001, NSCLC patients
|
100 percentage
Standard Deviation 0
|
—
|
99.8 percentage
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, melanoma patients
|
99.4 percentage
Standard Deviation 2.80
|
—
|
99.7 percentage
Standard Deviation 1.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
PDR001, melanoma patients
|
99.4 percentage
Standard Deviation 2.80
|
—
|
99.7 percentage
Standard Deviation 1.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, RCC patients
|
100 percentage
Standard Deviation 0
|
—
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
PDR001, RCC patients
|
100 percentage
Standard Deviation 0
|
—
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, mesothelioma patients
|
99.3 percentage
Standard Deviation 4.26
|
—
|
99.4 percentage
Standard Deviation 1.99
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
PDR001, mesothelioma patients
|
99.3 percentage
Standard Deviation 4.26
|
—
|
99.4 percentage
Standard Deviation 1.99
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
LAG525, TNBC patients
|
96.5 percentage
Standard Deviation 11.08
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
PDR001, TNBC patients
|
98.4 percentage
Standard Deviation 7.21
|
100 percentage
Standard Deviation 0
|
100 percentage
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=29 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, ROW patients
|
21.8 ug/mL
Standard Deviation 6.52
|
72.4 ug/mL
Standard Deviation 14.1
|
117 ug/mL
Standard Deviation 26.7
|
247 ug/mL
Standard Deviation 63.2
|
393 ug/mL
Standard Deviation 95.2
|
73.8 ug/mL
Standard Deviation 19.2
|
116 ug/mL
Standard Deviation 28.3
|
66.4 ug/mL
Standard Deviation 14.1
|
118 ug/mL
Standard Deviation 23.8
|
268 ug/mL
Standard Deviation 38.5
|
125 ug/mL
Standard Deviation 38.9
|
8.58 ug/mL
Standard Deviation 2.53
|
26.5 ug/mL
Standard Deviation 3.6
|
24.1 ug/mL
Standard Deviation 6.58
|
25.1 ug/mL
Standard Deviation 6.81
|
87.9 ug/mL
Standard Deviation 24.7
|
73.1 ug/mL
Standard Deviation 14.7
|
122 ug/mL
Standard Deviation 36.4
|
215 ug/mL
Standard Deviation 43.9
|
27.2 ug/mL
Standard Deviation 5.51
|
121 ug/mL
Standard Deviation 8.96
|
276 ug/mL
Standard Deviation 66.5
|
303 ug/mL
Standard Deviation 82.3
|
27.1 ug/mL
Standard Deviation 7.56
|
86.2 ug/mL
Standard Deviation 22.2
|
73.1 ug/mL
Standard Deviation 42.2
|
|
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, ROW patients
|
34.7 ug/mL
Standard Deviation 13.2
|
124 ug/mL
Standard Deviation 30.5
|
272 ug/mL
|
306 ug/mL
|
607 ug/mL
Standard Deviation 108
|
114 ug/mL
Standard Deviation 36.5
|
169 ug/mL
Standard Deviation 60.7
|
77.9 ug/mL
Standard Deviation 11
|
117 ug/mL
Standard Deviation 26.2
|
222 ug/mL
Standard Deviation 0
|
250 ug/mL
Standard Deviation 187
|
9.57 ug/mL
Standard Deviation 4.91
|
31.6 ug/mL
Standard Deviation 9.9
|
35.2 ug/mL
Standard Deviation 7.29
|
33.8 ug/mL
Standard Deviation 7.75
|
156 ug/mL
Standard Deviation 70.4
|
88.7 ug/mL
Standard Deviation 25.3
|
114 ug/mL
Standard Deviation 19.8
|
274 ug/mL
Standard Deviation 57.1
|
32 ug/mL
Standard Deviation 17
|
174 ug/mL
Standard Deviation 11.3
|
354 ug/mL
Standard Deviation 118
|
513 ug/mL
Standard Deviation 72.8
|
33.3 ug/mL
Standard Deviation 14.5
|
96 ug/mL
Standard Deviation 42.8
|
147 ug/mL
Standard Deviation 43
|
|
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, Japanese patients
|
23.1 ug/mL
Standard Deviation 2.58
|
—
|
—
|
—
|
—
|
95.5 ug/mL
Standard Deviation 18.3
|
152 ug/mL
Standard Deviation 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, Japanese patients
|
32.6 ug/mL
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
198 ug/mL
|
255 ug/mL
Standard Deviation 59.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=92 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, NSCLC patients
|
154 ug/mL
Standard Deviation 43.5
|
—
|
106 ug/mL
Standard Deviation 26.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, NSCLC patients
|
169 ug/mL
Standard Deviation 51.9
|
—
|
137 ug/mL
Standard Deviation 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, melanoma patients
|
115 ug/mL
Standard Deviation 29.9
|
—
|
102 ug/mL
Standard Deviation 36.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, melanoma patients
|
171 ug/mL
Standard Deviation 32
|
—
|
163 ug/mL
Standard Deviation 52.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, RCC patients
|
118 ug/mL
Standard Deviation 34.7
|
—
|
111 ug/mL
Standard Deviation 28.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, RCC patients
|
158 ug/mL
Standard Deviation 45.4
|
—
|
153 ug/mL
Standard Deviation 43.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, mesothelioma patients
|
116 ug/mL
Standard Deviation 31
|
—
|
119 ug/mL
Standard Deviation 37.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, mesothelioma patients
|
141 ug/mL
Standard Deviation 39.7
|
—
|
138 ug/mL
Standard Deviation 33.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 1, TNBC patients
|
144 ug/mL
Standard Deviation 32.4
|
207 ug/mL
Standard Deviation 53.1
|
132 ug/mL
Standard Deviation 26.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Cycle 3, TNBC patients
|
179 ug/mL
Standard Deviation 65.2
|
190 ug/mL
Standard Deviation 55
|
157 ug/mL
Standard Deviation 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=29 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, ROW patients
|
1.73 days
Interval 1.5 to 2.45
|
1.6 days
Interval 1.1 to 2.62
|
1.63 days
Interval 1.17 to 2.13
|
1.63 days
Interval 1.5 to 2.35
|
1.99 days
Interval 1.48 to 2.07
|
1.59 days
Interval 1.5 to 2.17
|
1.57 days
Interval 1.47 to 2.45
|
1.58 days
Interval 1.03 to 2.25
|
2.1 days
Interval 1.5 to 2.17
|
2.02 days
Interval 1.5 to 2.28
|
1.5 days
Interval 1.5 to 1.68
|
1.5 days
Interval 1.5 to 1.65
|
1.5 days
Interval 0.933 to 1.53
|
1.5 days
Interval 1.47 to 1.52
|
1.53 days
Interval 1.5 to 1.58
|
1.55 days
Interval 1.5 to 2.03
|
1.52 days
Interval 1.02 to 4.25
|
1.5 days
Interval 1.5 to 1.58
|
1.57 days
Interval 1.0 to 4.45
|
1.52 days
Interval 1.5 to 1.55
|
1.5 days
Interval 1.5 to 1.5
|
1.58 days
Interval 1.5 to 2.07
|
1.58 days
Interval 1.5 to 2.1
|
1.5 days
Interval 1.5 to 2.57
|
1.7 days
Interval 1.57 to 2.08
|
1.5 days
Interval 0.0 to 1.55
|
|
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, ROW patients
|
1.83 days
Interval 1.5 to 2.12
|
2.05 days
Interval 1.55 to 2.08
|
1.08 days
Interval 1.08 to 1.08
|
1.55 days
Interval 1.55 to 1.55
|
1.67 days
Interval 1.67 to 2.08
|
1.58 days
Interval 1.33 to 2.05
|
1.5 days
Interval 1.5 to 2.55
|
2.08 days
Interval 1.52 to 2.12
|
1.93 days
Interval 1.57 to 2.3
|
1.83 days
Interval 1.65 to 2.0
|
1.5 days
Interval 1.5 to 1.5
|
1.72 days
Interval 1.57 to 1.83
|
1.51 days
Interval 1.5 to 1.57
|
1.5 days
Interval 1.5 to 1.58
|
1.5 days
Interval 1.5 to 1.52
|
1.53 days
Interval 1.5 to 2.0
|
1.53 days
Interval 1.48 to 3.77
|
1.58 days
Interval 1.58 to 1.58
|
1.52 days
Interval 1.0 to 1.55
|
1.58 days
Interval 1.5 to 1.75
|
1.54 days
Interval 1.5 to 1.58
|
1.58 days
Interval 1.5 to 2.05
|
1.75 days
Interval 1.5 to 2.0
|
1.53 days
Interval 1.5 to 2.55
|
1.58 days
Interval 0.0 to 2.0
|
1.58 days
Interval 1.57 to 1.58
|
|
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, Japanese patients
|
1.58 days
Interval 1.55 to 1.68
|
—
|
—
|
—
|
—
|
1.54 days
Interval 1.5 to 1.63
|
1.54 days
Interval 1.52 to 1.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, Japanese patients
|
1.63 days
Interval 1.58 to 1.68
|
—
|
—
|
—
|
—
|
1.57 days
Interval 1.57 to 1.57
|
1.6 days
Interval 1.55 to 1.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=92 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, NSCLC patients
|
1.53 days
Interval 0.917 to 3.0
|
—
|
1.55 days
Interval 0.917 to 2.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, NSCLC patients
|
1.55 days
Interval 1.45 to 2.0
|
—
|
1.58 days
Interval 1.5 to 2.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, melanoma patients
|
1.51 days
Interval 1.43 to 3.0
|
—
|
1.53 days
Interval 1.07 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, melanoma patients
|
1.53 days
Interval 1.45 to 2.0
|
—
|
1.53 days
Interval 0.683 to 1.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, RCC patients
|
1.51 days
Interval 1.0 to 3.0
|
—
|
1.53 days
Interval 1.0 to 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, RCC patients
|
1.58 days
Interval 1.48 to 2.08
|
—
|
1.53 days
Interval 1.45 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, mesothelioma patients
|
1.53 days
Interval 0.583 to 3.0
|
—
|
1.55 days
Interval 1.47 to 2.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, mesothelioma patients
|
1.5 days
Interval 0.967 to 2.13
|
—
|
1.52 days
Interval 1.42 to 2.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 1, TNBC patients
|
1.53 days
Interval 0.567 to 3.0
|
1.53 days
Interval 1.43 to 3.0
|
1.58 days
Interval 0.95 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Cycle 3, TNBC patients
|
1.63 days
Interval 1.48 to 2.0
|
1.78 days
Interval 1.7 to 1.92
|
1.6 days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=29 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, ROW patients
|
136 day*ug/mL
Standard Deviation 49.2
|
506 day*ug/mL
Standard Deviation 111
|
758 day*ug/mL
Standard Deviation 172
|
1830 day*ug/mL
Standard Deviation 627
|
2810 day*ug/mL
Standard Deviation 555
|
500 day*ug/mL
Standard Deviation 147
|
708 day*ug/mL
Standard Deviation 199
|
631 day*ug/mL
Standard Deviation 184
|
1220 day*ug/mL
Standard Deviation 491
|
2230 day*ug/mL
Standard Deviation 731
|
1290 day*ug/mL
Standard Deviation 537
|
35.8 day*ug/mL
Standard Deviation 10.5
|
174 day*ug/mL
Standard Deviation 31.3
|
138 day*ug/mL
Standard Deviation 38.9
|
162 day*ug/mL
Standard Deviation 56.5
|
588 day*ug/mL
Standard Deviation 196
|
608 day*ug/mL
Standard Deviation 165
|
952 day*ug/mL
Standard Deviation 441
|
1640 day*ug/mL
Standard Deviation 539
|
198 day*ug/mL
Standard Deviation 101
|
1040 day*ug/mL
Standard Deviation 183
|
2890 day*ug/mL
Standard Deviation 982
|
3020 day*ug/mL
Standard Deviation 928
|
150 day*ug/mL
Standard Deviation 61.6
|
484 day*ug/mL
Standard Deviation 173
|
551 day*ug/mL
Standard Deviation 205
|
|
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, ROW patients
|
264 day*ug/mL
Standard Deviation 146
|
1000 day*ug/mL
Standard Deviation 358
|
2470 day*ug/mL
|
2330 day*ug/mL
|
5270 day*ug/mL
Standard Deviation 1250
|
862 day*ug/mL
Standard Deviation 583
|
1390 day*ug/mL
Standard Deviation 759
|
928 day*ug/mL
Standard Deviation 469
|
1200 day*ug/mL
Standard Deviation 754
|
1770 day*ug/mL
Standard Deviation 2230
|
2740 day*ug/mL
Standard Deviation 2680
|
59.9 day*ug/mL
Standard Deviation 39.3
|
286 day*ug/mL
Standard Deviation 134
|
264 day*ug/mL
Standard Deviation 133
|
234 day*ug/mL
Standard Deviation 108
|
1310 day*ug/mL
Standard Deviation 701
|
869 day*ug/mL
Standard Deviation 328
|
1410 day*ug/mL
Standard Deviation 831
|
1990 day*ug/mL
Standard Deviation 1180
|
336 day*ug/mL
Standard Deviation 439
|
2250 day*ug/mL
Standard Deviation 44.7
|
3840 day*ug/mL
Standard Deviation 1600
|
7160 day*ug/mL
Standard Deviation 3190
|
211 day*ug/mL
Standard Deviation 150
|
938 day*ug/mL
Standard Deviation 141
|
1230 day*ug/mL
Standard Deviation 617
|
|
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, Japanese patients
|
144 day*ug/mL
Standard Deviation 35.6
|
—
|
—
|
—
|
—
|
679 day*ug/mL
Standard Deviation 142
|
1130 day*ug/mL
Standard Deviation 153
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, Japanese patients
|
89.6 day*ug/mL
Standard Deviation 76.7
|
—
|
—
|
—
|
—
|
1720 day*ug/mL
|
2520 day*ug/mL
Standard Deviation 359
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=92 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, NSCLC patients
|
1260 day*ug/mL
Standard Deviation 509
|
—
|
955 day*ug/mL
Standard Deviation 272
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, NSCLC patients
|
1500 day*ug/mL
Standard Deviation 688
|
—
|
1260 day*ug/mL
Standard Deviation 554
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, melanoma patients
|
1030 day*ug/mL
Standard Deviation 404
|
—
|
953 day*ug/mL
Standard Deviation 340
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, melanoma patients
|
1860 day*ug/mL
Standard Deviation 507
|
—
|
1680 day*ug/mL
Standard Deviation 754
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, RCC patients
|
979 day*ug/mL
Standard Deviation 366
|
—
|
886 day*ug/mL
Standard Deviation 429
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, RCC patients
|
1420 day*ug/mL
Standard Deviation 678
|
—
|
1280 day*ug/mL
Standard Deviation 809
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, mesothelioma patients
|
963 day*ug/mL
Standard Deviation 329
|
—
|
1070 day*ug/mL
Standard Deviation 350
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, mesothelioma patients
|
1400 day*ug/mL
Standard Deviation 732
|
—
|
1380 day*ug/mL
Standard Deviation 729
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 1, TNBC patients
|
1180 day*ug/mL
Standard Deviation 379
|
2010 day*ug/mL
Standard Deviation 807
|
1150 day*ug/mL
Standard Deviation 234
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Cycle 3, TNBC patients
|
1710 day*ug/mL
Standard Deviation 1090
|
2800 day*ug/mL
Standard Deviation 1210
|
1530 day*ug/mL
Standard Deviation 578
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=29 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, ROW patients
|
7.65 days
Standard Deviation 1.94
|
11.1 days
Standard Deviation 4.12
|
9.99 days
Standard Deviation 2.37
|
12 days
Standard Deviation 4.5
|
12.8 days
Standard Deviation 8
|
10.3 days
Standard Deviation 3.5
|
11.5 days
Standard Deviation 6.59
|
13.5 days
Standard Deviation 4.07
|
13.1 days
Standard Deviation 5.38
|
13.9 days
Standard Deviation 5.15
|
13.6 days
Standard Deviation 7.61
|
3.47 days
Standard Deviation 1.4
|
9.15 days
Standard Deviation 3.86
|
6.5 days
Standard Deviation 3.25
|
7.52 days
Standard Deviation 2.5
|
9.5 days
Standard Deviation 2.78
|
11.5 days
Standard Deviation 3.7
|
11.3 days
Standard Deviation 4.94
|
10.2 days
Standard Deviation 3.68
|
7.49 days
Standard Deviation 4.42
|
15.7 days
Standard Deviation 4.23
|
17.9 days
Standard Deviation 7.88
|
14.4 days
Standard Deviation 3.28
|
5.26 days
Standard Deviation 2.43
|
9.12 days
Standard Deviation 2.07
|
9.36 days
Standard Deviation 2.18
|
|
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, ROW patients
|
11.2 days
Standard Deviation 2.62
|
14.4 days
Standard Deviation 5.82
|
5.94 days
|
12.2 days
|
16.5 days
Standard Deviation 2.87
|
12.1 days
Standard Deviation 5.06
|
18 days
Standard Deviation 9.7
|
15 days
Standard Deviation 2.36
|
20.6 days
Standard Deviation 8.51
|
20.8 days
|
23.4 days
Standard Deviation 14.6
|
6.15 days
Standard Deviation 2.98
|
9.55 days
Standard Deviation 3.95
|
9.17 days
Standard Deviation 4.36
|
13.1 days
Standard Deviation 0.736
|
14.7 days
|
14.3 days
Standard Deviation 7.02
|
14.5 days
Standard Deviation 1.24
|
13.8 days
Standard Deviation 4.45
|
11.1 days
Standard Deviation 10.9
|
18.3 days
Standard Deviation 3.58
|
15.1 days
Standard Deviation 5.44
|
26.3 days
Standard Deviation 11.9
|
7.32 days
Standard Deviation 4.94
|
10.8 days
Standard Deviation 1.76
|
15.1 days
Standard Deviation 4.54
|
|
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, Japanese patients
|
13.7 days
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
9.42 days
Standard Deviation 2.27
|
13.8 days
Standard Deviation 4.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, Japanese patients
|
5.49 days
Standard Deviation 2.38
|
—
|
—
|
—
|
—
|
19.4 days
|
28.1 days
Standard Deviation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and had a valid measure of the endpoint.
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=84 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=13 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=64 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, TNBC patients
|
18.7 days
Standard Deviation 9.14
|
—
|
19 days
Standard Deviation 4.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, NSCLC patients
|
11.6 days
Standard Deviation 6.11
|
—
|
13.3 days
Standard Deviation 4.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, NSCLC patients
|
16.3 days
Standard Deviation 9.17
|
—
|
15.9 days
Standard Deviation 7.88
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, melanoma patients
|
15.6 days
Standard Deviation 5.18
|
—
|
15.5 days
Standard Deviation 5.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, melanoma patients
|
20.1 days
Standard Deviation 5.24
|
—
|
19.2 days
Standard Deviation 9.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, RCC patients
|
14.2 days
Standard Deviation 3.61
|
—
|
14.1 days
Standard Deviation 5.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, RCC patients
|
14.1 days
Standard Deviation 3.71
|
—
|
23.1 days
Standard Deviation 6.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, mesothelioma patients
|
13 days
Standard Deviation 5.13
|
—
|
13.7 days
Standard Deviation 5.27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 3, mesothelioma patients
|
18.4 days
Standard Deviation 7.16
|
—
|
18.7 days
Standard Deviation 5.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Cycle 1, TNBC patients
|
22.5 days
Standard Deviation 18.9
|
14.6 days
Standard Deviation 3.82
|
14.4 days
Standard Deviation 5.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 1, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19.6 ug/mL
Standard Deviation 3.59
|
19.6 ug/mL
Standard Deviation 2.77
|
17.7 ug/mL
Standard Deviation 3.84
|
58.8 ug/mL
Standard Deviation 23.2
|
67.9 ug/mL
Standard Deviation 20.4
|
76.2 ug/mL
Standard Deviation 20
|
61.5 ug/mL
Standard Deviation 22.1
|
85.1 ug/mL
Standard Deviation 28
|
65 ug/mL
Standard Deviation 11.3
|
87.6 ug/mL
Standard Deviation 24.5
|
113 ug/mL
Standard Deviation 26.8
|
116 ug/mL
Standard Deviation 28.1
|
100 ug/mL
Standard Deviation 23.1
|
115 ug/mL
Standard Deviation 33.2
|
97.9 ug/mL
Standard Deviation 17
|
|
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
30.4 ug/mL
Standard Deviation 11.9
|
28.7 ug/mL
Standard Deviation 8.4
|
29.7 ug/mL
Standard Deviation 9.97
|
89.5 ug/mL
Standard Deviation 28.9
|
168 ug/mL
Standard Deviation 20.1
|
97.5 ug/mL
Standard Deviation 34.4
|
80 ug/mL
Standard Deviation 25.1
|
123 ug/mL
Standard Deviation 35.6
|
90.8 ug/mL
Standard Deviation 51.2
|
142 ug/mL
|
134 ug/mL
Standard Deviation 56.7
|
167 ug/mL
Standard Deviation 9.9
|
141 ug/mL
Standard Deviation 58.2
|
147 ug/mL
Standard Deviation 29.8
|
126 ug/mL
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=92 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 1, NSCLC patients
|
102 ug/mL
Standard Deviation 33
|
—
|
68.9 ug/mL
Standard Deviation 17.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3, NSCLC patients
|
118 ug/mL
Standard Deviation 36.5
|
—
|
100 ug/mL
Standard Deviation 24.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 1, melanoma patients
|
75.7 ug/mL
Standard Deviation 25.2
|
—
|
71.3 ug/mL
Standard Deviation 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3, melanoma patients
|
117 ug/mL
Standard Deviation 29.8
|
—
|
105 ug/mL
Standard Deviation 43.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 1, RCC patients
|
81 ug/mL
Standard Deviation 21.3
|
—
|
67 ug/mL
Standard Deviation 25.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3, RCC patients
|
104 ug/mL
Standard Deviation 23.8
|
—
|
103 ug/mL
Standard Deviation 36.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 1, mesothelioma patients
|
70.5 ug/mL
Standard Deviation 21.4
|
—
|
82.7 ug/mL
Standard Deviation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3, mesothelioma patients
|
96.5 ug/mL
Standard Deviation 31.5
|
—
|
113 ug/mL
Standard Deviation 36.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 1, TNBC patients
|
91.5 ug/mL
Standard Deviation 25.1
|
117 ug/mL
Standard Deviation 36.7
|
89.8 ug/mL
Standard Deviation 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Cycle 3, TNBC patients
|
124 ug/mL
Standard Deviation 36.5
|
134 ug/mL
Standard Deviation 54
|
123 ug/mL
Standard Deviation 18.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 1, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.5 days
Interval 1.47 to 1.62
|
1.5 days
Interval 1.1 to 1.55
|
1.55 days
Interval 1.42 to 1.63
|
1.63 days
Interval 1.52 to 1.78
|
1.51 days
Interval 0.95 to 1.67
|
1.53 days
Interval 0.467 to 2.42
|
1.75 days
Interval 1.5 to 2.08
|
1.53 days
Interval 1.45 to 2.5
|
1.58 days
Interval 1.5 to 2.02
|
1.5 days
Interval 1.47 to 1.72
|
1.66 days
Interval 1.5 to 2.07
|
1.5 days
Interval 0.583 to 1.58
|
1.5 days
Interval 1.5 to 1.58
|
1.58 days
Interval 0.683 to 2.12
|
1.56 days
Interval 1.47 to 1.68
|
|
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.5 days
Interval 1.07 to 1.65
|
1.58 days
Interval 1.57 to 1.68
|
1.55 days
Interval 1.52 to 1.58
|
1.72 days
Interval 1.57 to 17.2
|
1.75 days
Interval 1.58 to 2.08
|
1.5 days
Interval 0.45 to 1.72
|
1.5 days
Interval 1.5 to 1.62
|
1.58 days
Interval 1.0 to 2.13
|
1.63 days
Interval 1.58 to 1.67
|
1.8 days
Interval 1.8 to 1.8
|
1.53 days
Interval 1.45 to 2.08
|
1.87 days
Interval 1.57 to 2.17
|
1.55 days
Interval 1.52 to 1.6
|
1.55 days
Interval 0.533 to 2.12
|
1.58 days
Interval 1.52 to 1.68
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=92 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 1, NSCLC patients
|
1.57 days
Interval 1.52 to 3.0
|
—
|
1.57 days
Interval 1.0 to 2.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3, NSCLC patients
|
1.57 days
Interval 1.32 to 2.08
|
—
|
1.58 days
Interval 1.47 to 2.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 1, melanoma patients
|
1.55 days
Interval 0.35 to 3.08
|
—
|
1.53 days
Interval 0.567 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3, melanoma patients
|
1.57 days
Interval 1.08 to 2.08
|
—
|
1.53 days
Interval 0.583 to 1.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 1, RCC patients
|
1.58 days
Interval 1.0 to 3.08
|
—
|
1.57 days
Interval 0.55 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3, RCC patients
|
1.53 days
Interval 1.5 to 2.08
|
—
|
1.58 days
Interval 1.47 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 1, mesothelioma patients
|
1.55 days
Interval 0.483 to 3.0
|
—
|
1.54 days
Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3, mesothelioma patients
|
1.52 days
Interval 0.1 to 2.05
|
—
|
1.5 days
Interval 0.283 to 2.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 1, TNBC patients
|
1.58 days
Interval 0.5 to 3.0
|
1.57 days
Interval 1.45 to 2.92
|
1.53 days
Interval 0.967 to 2.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Cycle 3, TNBC patients
|
1.6 days
Interval 1.48 to 2.5
|
1.75 days
Interval 1.6 to 2.43
|
1.65 days
Interval 1.5 to 2.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 1, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
114 day*ug/mL
Standard Deviation 17
|
141 day*ug/mL
Standard Deviation 45.4
|
134 day*ug/mL
Standard Deviation 25.7
|
437 day*ug/mL
Standard Deviation 177
|
466 day*ug/mL
Standard Deviation 159
|
601 day*ug/mL
Standard Deviation 238
|
537 day*ug/mL
Standard Deviation 163
|
637 day*ug/mL
Standard Deviation 263
|
591 day*ug/mL
Standard Deviation 207
|
789 day*ug/mL
Standard Deviation 319
|
1290 day*ug/mL
Standard Deviation 441
|
1190 day*ug/mL
Standard Deviation 353
|
1080 day*ug/mL
Standard Deviation 412
|
1110 day*ug/mL
Standard Deviation 335
|
950 day*ug/mL
Standard Deviation 264
|
|
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 3, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
292 day*ug/mL
Standard Deviation 131
|
268 day*ug/mL
Standard Deviation 151
|
289 day*ug/mL
Standard Deviation 196
|
816 day*ug/mL
Standard Deviation 472
|
1340 day*ug/mL
Standard Deviation 673
|
1180 day*ug/mL
Standard Deviation 447
|
1020 day*ug/mL
Standard Deviation 563
|
939 day*ug/mL
Standard Deviation 572
|
1500 day*ug/mL
Standard Deviation 1450
|
1860 day*ug/mL
Standard Deviation 150
|
1950 day*ug/mL
Standard Deviation 645
|
2840 day*ug/mL
Standard Deviation 531
|
1440 day*ug/mL
Standard Deviation 828
|
1510 day*ug/mL
Standard Deviation 874
|
1310 day*ug/mL
Standard Deviation 700
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=92 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 1, NSCLC patients
|
853 day*ug/mL
Standard Deviation 347
|
—
|
629 day*ug/mL
Standard Deviation 197
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 3, NSCLC patients
|
1020 day*ug/mL
Standard Deviation 500
|
—
|
881 day*ug/mL
Standard Deviation 443
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 1, melanoma patients
|
663 day*ug/mL
Standard Deviation 291
|
—
|
633 day*ug/mL
Standard Deviation 310
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 3, melanoma patients
|
1390 day*ug/mL
Standard Deviation 406
|
—
|
1070 day*ug/mL
Standard Deviation 537
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 1, RCC patients
|
739 day*ug/mL
Standard Deviation 227
|
—
|
617 day*ug/mL
Standard Deviation 347
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 3, RCC patients
|
879 day*ug/mL
Standard Deviation 547
|
—
|
1060 day*ug/mL
Standard Deviation 464
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 1, mesothelioma patients
|
633 day*ug/mL
Standard Deviation 263
|
—
|
747 day*ug/mL
Standard Deviation 388
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 3, mesothelioma patients
|
1110 day*ug/mL
Standard Deviation 500
|
—
|
1110 day*ug/mL
Standard Deviation 606
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 1, TNBC patients
|
808 day*ug/mL
Standard Deviation 331
|
1110 day*ug/mL
Standard Deviation 621
|
766 day*ug/mL
Standard Deviation 277
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Cycle 3, TNBC patients
|
1370 day*ug/mL
Standard Deviation 570
|
2150 day*ug/mL
Standard Deviation 1180
|
1360 day*ug/mL
Standard Deviation 351
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=5 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=11 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 1, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.71 day
Standard Deviation 8.24
|
10.2 day
Standard Deviation 4.81
|
12.5 day
Standard Deviation 3.38
|
20.7 day
Standard Deviation 8.72
|
30.8 day
Standard Deviation 47
|
22.8 day
Standard Deviation 13.8
|
14.8 day
Standard Deviation 4.78
|
11.8 day
Standard Deviation 5
|
14 day
Standard Deviation 3.72
|
15.1 day
Standard Deviation 10.2
|
20.4 day
Standard Deviation 8.41
|
18.7 day
Standard Deviation 7.18
|
20.4 day
Standard Deviation 10
|
14.6 day
Standard Deviation 5.48
|
17.3 day
Standard Deviation 2.76
|
|
Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 3, ROW patients
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.4 day
Standard Deviation 9.4
|
22.3 day
Standard Deviation 7.13
|
12.4 day
Standard Deviation 10.3
|
17.8 day
Standard Deviation 5.03
|
44.4 day
Standard Deviation 36.8
|
27.7 day
Standard Deviation 19.4
|
27.4 day
Standard Deviation 4.25
|
17.4 day
Standard Deviation 5.64
|
20.8 day
Standard Deviation 12.4
|
22.4 day
|
21.9 day
Standard Deviation 4.22
|
32.8 day
Standard Deviation 12.5
|
16.7 day
Standard Deviation 10.2
|
16.1 day
Standard Deviation 5.64
|
24.9 day
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).Population: All patients in phase 2 who received at least one full or partial dose of PDR001 and had a valid measure of the endpoint.
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=89 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=15 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=61 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 1, NSCLC patients
|
17.2 days
Standard Deviation 10
|
—
|
15.8 days
Standard Deviation 5.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 3, NSCLC patients
|
16.8 days
Standard Deviation 7.88
|
—
|
24.5 days
Standard Deviation 8.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 1, melanoma patients
|
29.1 days
Standard Deviation 31.6
|
—
|
20 days
Standard Deviation 5.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 3, melanoma patients
|
24.2 days
Standard Deviation 6.17
|
—
|
25.6 days
Standard Deviation 15.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 1, RCC patients
|
17.8 days
Standard Deviation 4.77
|
—
|
18.4 days
Standard Deviation 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 3, RCC patients
|
18.4 days
Standard Deviation 5.02
|
—
|
24.2 days
Standard Deviation 5.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 1, mesothelioma patients
|
19.1 days
Standard Deviation 7.98
|
—
|
25.6 days
Standard Deviation 7.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 3, mesothelioma patients
|
25.2 days
Standard Deviation 14.5
|
—
|
17.3 days
Standard Deviation 8.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 1, TNBC patients
|
18.8 days
Standard Deviation 8.33
|
21.3 days
Standard Deviation 7.43
|
19.9 days
Standard Deviation 6.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Cycle 3, TNBC patients
|
23.9 days
Standard Deviation 17.1
|
22.2 days
Standard Deviation 0.591
|
23.8 days
Standard Deviation 5.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).Population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable. Japanese patients were analyzed together with the rest of the world (ROW) patients.
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=14 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=11 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=4 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=5 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=21 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=17 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=4 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=7 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=5 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=15 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=3 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=8 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=6 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=3 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=9 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=5 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=10 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=5 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Anti-LAG525 Antibodies
ADA-negative at baseline
|
14 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
19 Participants
|
15 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
12 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
5 Participants
|
5 Participants
|
|
Phase 1: Number of Participants With Anti-LAG525 Antibodies
ADA-positive at post-baseline
|
6 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.
Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=106 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=16 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=80 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-negative at baseline, NSCLC patients
|
19 Participants
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-positive at post-baseline, NSCLC patients
|
4 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-negative at baseline, melanoma patients
|
15 Participants
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-positive at post-baseline, melanoma patients
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-negative at baseline, RCC patients
|
17 Participants
|
—
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-positive at post-baseline, RCC patients
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-negative at baseline, mesothelioma patients
|
35 Participants
|
—
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-positive at post-baseline, mesothelioma patients
|
3 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-negative at baseline, TNBC patients
|
15 Participants
|
15 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-LAG525 Antibodies
ADA-positive at post-baseline, TNBC patients
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).Population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=5 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=16 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=2 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=7 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=5 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=2 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=3 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
14 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Phase 1: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at post-baseline (i.e. ADA incidence)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).Population: All patients in phase 2 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.
Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=108 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=14 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=82 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at post-baseline, mesothelioma patients
|
6 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline, NSCLC patients
|
18 Participants
|
—
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at post-baseline, NSCLC patients
|
6 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline, melanoma patients
|
16 Participants
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at post-baseline, melanoma patients
|
5 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline, RCC patients
|
17 Participants
|
—
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at post-baseline, RCC patients
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline, mesothelioma patients
|
32 Participants
|
—
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-negative at baseline, TNBC patients
|
17 Participants
|
13 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With Anti-PDR001 Antibodies
ADA-positive at post-baseline, TNBC patients
|
5 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
ROW
|
0 percentage of participants
Interval 0.0 to 20.6
|
0 percentage of participants
Interval 0.0 to 22.1
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 11.3
|
0 percentage of participants
Interval 0.0 to 11.7
|
0 percentage of participants
Interval 0.0 to 45.1
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 23.8
|
0 percentage of participants
Interval 0.0 to 45.1
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
0 percentage of participants
Interval 0.0 to 39.3
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 45.1
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
20.0 percentage of participants
Interval 7.1 to 40.1
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
0 percentage of participants
Interval 0.0 to 22.1
|
0 percentage of participants
Interval 0.0 to 34.8
|
0 percentage of participants
Interval 0.0 to 39.3
|
16.7 percentage of participants
Interval 3.0 to 43.8
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 23.8
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 39.3
|
|
Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
Japanese
|
0 percentage of participants
Interval 0.0 to 52.7
|
—
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 45.1
|
0 percentage of participants
Interval 0.0 to 39.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Response Rate (ORR) Per irRC
ROW
|
0 percentage of participants
Interval 0.0 to 20.6
|
0 percentage of participants
Interval 0.0 to 22.1
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 11.3
|
0 percentage of participants
Interval 0.0 to 11.7
|
0 percentage of participants
Interval 0.0 to 45.1
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 23.8
|
0 percentage of participants
Interval 0.0 to 45.1
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
0 percentage of participants
Interval 0.0 to 39.3
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 45.1
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
20.0 percentage of participants
Interval 7.1 to 40.1
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
0 percentage of participants
Interval 0.0 to 22.1
|
0 percentage of participants
Interval 0.0 to 34.8
|
0 percentage of participants
Interval 0.0 to 39.3
|
33.3 percentage of participants
Interval 12.3 to 60.9
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 23.8
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 39.3
|
|
Phase 1: Overall Response Rate (ORR) Per irRC
Japanese
|
0 percentage of participants
Interval 0.0 to 52.7
|
—
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 45.1
|
0 percentage of participants
Interval 0.0 to 39.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR) Per irRC
Melanoma
|
15.0 percentage of participants
Interval 4.2 to 34.4
|
—
|
9.1 percentage of participants
Interval 1.6 to 25.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per irRC
Non-small cell lung cancer (NSCLC)
|
15.0 percentage of participants
Interval 4.2 to 34.4
|
—
|
0 percentage of participants
Interval 0.0 to 12.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per irRC
Renal cell cancer (RCC)
|
26.3 percentage of participants
Interval 11.0 to 47.6
|
—
|
5.3 percentage of participants
Interval 0.3 to 22.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per irRC
Mesothelioma
|
19.5 percentage of participants
Interval 10.1 to 32.5
|
—
|
6.3 percentage of participants
Interval 0.3 to 26.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Overall Response Rate (ORR) Per irRC
Triple negative breast cancer (TNBC)
|
14.3 percentage of participants
Interval 4.0 to 32.9
|
4.8 percentage of participants
Interval 0.2 to 20.7
|
0 percentage of participants
Interval 0.0 to 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
ROW
|
23.1 percentage of participants
Interval 6.6 to 49.5
|
41.7 percentage of participants
Interval 18.1 to 68.5
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 39.3
|
66.7 percentage of participants
Interval 27.1 to 93.7
|
24.0 percentage of participants
Interval 11.0 to 42.0
|
20.8 percentage of participants
Interval 8.6 to 38.9
|
20.0 percentage of participants
Interval 1.0 to 65.7
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
18.2 percentage of participants
Interval 3.3 to 47.0
|
20.0 percentage of participants
Interval 1.0 to 65.7
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
60.0 percentage of participants
Interval 18.9 to 92.4
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
55.0 percentage of participants
Interval 34.7 to 74.1
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
8.3 percentage of participants
Interval 0.4 to 33.9
|
28.6 percentage of participants
Interval 5.3 to 65.9
|
66.7 percentage of participants
Interval 27.1 to 93.7
|
41.7 percentage of participants
Interval 18.1 to 68.5
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
36.4 percentage of participants
Interval 13.5 to 65.0
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
|
Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
Japanese
|
25.0 percentage of participants
Interval 1.3 to 75.1
|
—
|
—
|
—
|
—
|
40.0 percentage of participants
Interval 7.6 to 81.1
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR) Per irRC
ROW
|
30.8 percentage of participants
Interval 11.3 to 57.3
|
33.3 percentage of participants
Interval 12.3 to 60.9
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
0 percentage of participants
Interval 0.0 to 39.3
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
28.0 percentage of participants
Interval 13.9 to 46.2
|
33.3 percentage of participants
Interval 17.8 to 52.1
|
20.0 percentage of participants
Interval 1.0 to 65.7
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
18.2 percentage of participants
Interval 3.3 to 47.0
|
20.0 percentage of participants
Interval 1.0 to 65.7
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
66.7 percentage of participants
Interval 27.1 to 93.7
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
60.0 percentage of participants
Interval 18.9 to 92.4
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
55.0 percentage of participants
Interval 34.7 to 74.1
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
8.3 percentage of participants
Interval 0.4 to 33.9
|
28.6 percentage of participants
Interval 5.3 to 65.9
|
66.7 percentage of participants
Interval 27.1 to 93.7
|
50.0 percentage of participants
Interval 24.5 to 75.5
|
33.3 percentage of participants
Interval 6.3 to 72.9
|
36.4 percentage of participants
Interval 13.5 to 65.0
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
50.0 percentage of participants
Interval 15.3 to 84.7
|
|
Phase 1: Disease Control Rate (DCR) Per irRC
Japanese
|
25.0 percentage of participants
Interval 1.3 to 75.1
|
—
|
—
|
—
|
—
|
40.0 percentage of participants
Interval 7.6 to 81.1
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Non-small cell lung cancer (NSCLC)
|
50.0 percentage of participants
Interval 30.2 to 69.8
|
—
|
50.0 percentage of participants
Interval 31.1 to 68.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Melanoma
|
45.0 percentage of participants
Interval 25.9 to 65.3
|
—
|
40.9 percentage of participants
Interval 23.3 to 60.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Renal cell cancer (RCC)
|
63.2 percentage of participants
Interval 41.8 to 81.2
|
—
|
42.1 percentage of participants
Interval 23.0 to 63.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Mesothelioma
|
65.9 percentage of participants
Interval 51.9 to 78.0
|
—
|
56.3 percentage of participants
Interval 33.3 to 77.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Triple negative breast cancer (TNBC)
|
33.3 percentage of participants
Interval 16.8 to 53.6
|
23.8 percentage of participants
Interval 9.9 to 43.7
|
21.4 percentage of participants
Interval 6.1 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment until end of treatment, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate (DCR) Per irRC
Non-small cell lung cancer (NSCLC)
|
60.0 percentage of participants
Interval 39.4 to 78.3
|
—
|
50.0 percentage of participants
Interval 31.1 to 68.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per irRC
Melanoma
|
55.0 percentage of participants
Interval 34.7 to 74.1
|
—
|
40.9 percentage of participants
Interval 23.3 to 60.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per irRC
Renal cell cancer (RCC)
|
68.4 percentage of participants
Interval 47.0 to 85.3
|
—
|
42.1 percentage of participants
Interval 23.0 to 63.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per irRC
Mesothelioma
|
65.9 percentage of participants
Interval 51.9 to 78.0
|
—
|
56.3 percentage of participants
Interval 33.3 to 77.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Disease Control Rate (DCR) Per irRC
Triple negative breast cancer (TNBC)
|
33.3 percentage of participants
Interval 16.8 to 53.6
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
21.4 percentage of participants
Interval 6.1 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=2 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=1 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=1 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=4 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=2 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=2 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=1 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DOR) Per RECIST 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
12.2 months
Not estimable due to insufficient number of participants with events.
|
NA months
Interval 7.9 to
Not estimable due to insufficient number of participants with events.
|
18.4 months
Interval 2.8 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
6.5 months
Interval 5.6 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=2 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=1 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=1 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=4 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=2 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=4 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=1 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DOR) Per irRC
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
12.2 months
Not estimable due to insufficient number of participants with events.
|
NA months
Interval 7.9 to
Not estimable due to insufficient number of participants with events.
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
9.2 months
Interval 4.4 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. DOR is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=21 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=1 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=4 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR) Per RECIST 1.1
Non-small cell lung cancer (NSCLC)
|
5.0 months
Interval 3.7 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per RECIST 1.1
Melanoma
|
11.0 months
Interval 4.2 to
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Interval 18.2 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per RECIST 1.1
Renal cell cancer (RCC)
|
NA months
Interval 7.6 to
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per RECIST 1.1
Mesothelioma
|
NA months
Interval 5.8 to
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per RECIST 1.1
Triple negative breast cancer (TNBC)
|
NA months
Interval 7.6 to
Not estimable due to insufficient number of participants with events.
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. DOR is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=22 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=1 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=4 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR) Per irRC
Non-small cell lung cancer (NSCLC)
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per irRC
Melanoma
|
17.5 months
Interval 11.0 to
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Interval 18.2 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per irRC
Renal cell cancer (RCC)
|
NA months
Interval 7.6 to
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per irRC
Mesothelioma
|
NA months
Interval 5.8 to
Not estimable due to insufficient number of participants with events.
|
—
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR) Per irRC
Triple negative breast cancer (TNBC)
|
NA months
Interval 7.6 to
Not estimable due to insufficient number of participants with events.
|
NA months
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
ROW
|
1.8 months
Interval 1.6 to 2.0
|
2.3 months
Interval 1.7 to 3.5
|
1.6 months
Interval 0.8 to 1.9
|
1.9 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
7.9 months
Interval 1.3 to
Not estimable due to insufficient number of participants with events.
|
1.7 months
Interval 1.6 to 1.9
|
1.8 months
Interval 1.5 to 1.9
|
2.8 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
2.1 months
Interval 0.3 to
Not estimable due to insufficient number of participants with events.
|
1.8 months
Interval 1.0 to 2.0
|
1.5 months
Interval 1.4 to
Not estimable due to insufficient number of participants with events.
|
3.8 months
Interval 1.3 to
Not estimable due to insufficient number of participants with events.
|
1.9 months
Interval 1.8 to 3.5
|
1.8 months
Interval 1.1 to 3.4
|
8.4 months
Interval 1.7 to
Not estimable due to insufficient number of participants with events.
|
1.8 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
2.8 months
Interval 2.0 to 4.2
|
6.5 months
Interval 0.6 to
Not estimable due to insufficient number of participants with events.
|
1.4 months
Interval 0.6 to 1.8
|
1.8 months
Interval 1.2 to 2.5
|
3.1 months
Interval 1.0 to 5.0
|
2.3 months
Interval 1.6 to 5.7
|
1.5 months
Interval 0.9 to
Not estimable due to insufficient number of participants with events.
|
1.9 months
Interval 1.7 to 2.9
|
3.8 months
Interval 1.6 to 7.6
|
3.2 months
Interval 1.7 to 5.8
|
|
Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
Japanese
|
1.8 months
Interval 1.2 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
1.8 months
Interval 1.0 to
Not estimable due to insufficient number of participants with events.
|
1.7 months
Interval 1.2 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 yearsPopulation: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported for ROW and Japanese patients.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=17 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 Participants
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 Participants
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=30 Participants
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
n=30 Participants
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 Participants
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 Participants
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 Participants
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 Participants
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 Participants
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 Participants
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 Participants
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 Participants
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 Participants
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 Participants
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 Participants
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 Participants
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 Participants
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 Participants
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression-free Survival (PFS) Per irRC
ROW
|
1.9 months
Interval 1.6 to 2.7
|
1.9 months
Interval 1.7 to 3.4
|
1.6 months
Interval 0.8 to 1.9
|
1.9 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
3.4 months
Interval 1.3 to
Not estimable due to insufficient number of participants with events.
|
1.8 months
Interval 1.6 to 1.9
|
1.9 months
Interval 1.5 to 2.3
|
2.8 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
2.6 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
1.8 months
Interval 1.0 to 2.0
|
1.5 months
Interval 1.4 to
Not estimable due to insufficient number of participants with events.
|
3.8 months
Interval 1.3 to
Not estimable due to insufficient number of participants with events.
|
4.2 months
Interval 1.8 to
Not estimable due to insufficient number of participants with events.
|
2.6 months
Interval 1.1 to
Not estimable due to insufficient number of participants with events.
|
8.4 months
Interval 1.7 to
Not estimable due to insufficient number of participants with events.
|
1.8 months
Interval 1.6 to
Not estimable due to insufficient number of participants with events.
|
2.8 months
Interval 2.0 to 4.2
|
7.5 months
Interval 0.6 to
Not estimable due to insufficient number of participants with events.
|
1.6 months
Interval 0.6 to 1.8
|
2.0 months
Interval 1.5 to 2.5
|
3.1 months
Interval 1.0 to 5.0
|
3.2 months
Interval 1.7 to 9.1
|
1.5 months
Interval 0.9 to
Not estimable due to insufficient number of participants with events.
|
2.0 months
Interval 1.7 to 4.2
|
3.8 months
Interval 1.6 to 7.6
|
3.2 months
Interval 1.7 to 5.8
|
|
Phase 1: Progression-free Survival (PFS) Per irRC
Japanese
|
1.8 months
Interval 1.2 to
Not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
1.8 months
Interval 1.0 to
Not estimable due to insufficient number of participants with events.
|
1.7 months
Interval 1.2 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Non-small cell lung cancer (NSCLC)
|
3.9 months
Interval 1.7 to 5.6
|
—
|
3.5 months
Interval 1.9 to 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Melanoma
|
2.2 months
Interval 1.6 to 5.6
|
—
|
1.9 months
Interval 1.8 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Renal cell cancer (RCC)
|
4.4 months
Interval 2.1 to 11.1
|
—
|
3.0 months
Interval 1.6 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Mesothelioma
|
5.5 months
Interval 3.5 to 6.4
|
—
|
3.4 months
Interval 1.8 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Triple negative breast cancer (TNBC)
|
1.9 months
Interval 1.5 to 3.5
|
1.8 months
Interval 1.4 to 2.6
|
1.7 months
Interval 1.3 to 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 yearsPopulation: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported by tumor type.
Outcome measures
| Measure |
Phase 1: LAG525 1 mg/kg Q2W
n=121 Participants
Single-agent LAG525 1 mg/kg Q2W
|
Phase 1: LAG525 3 mg/kg Q2W
n=21 Participants
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=93 Participants
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
|
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
|
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Progression-free Survival (PFS) Per irRC
Triple negative breast cancer (TNBC)
|
1.9 months
Interval 1.5 to 3.8
|
1.9 months
Interval 1.4 to 3.6
|
1.7 months
Interval 1.3 to 3.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per irRC
Non-small cell lung cancer (NSCLC)
|
4.2 months
Interval 1.7 to 7.4
|
—
|
3.5 months
Interval 1.9 to 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per irRC
Melanoma
|
5.4 months
Interval 1.6 to 5.6
|
—
|
1.9 months
Interval 1.8 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per irRC
Renal cell cancer (RCC)
|
5.8 months
Interval 4.4 to 11.1
|
—
|
3.0 months
Interval 1.6 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Progression-free Survival (PFS) Per irRC
Mesothelioma
|
5.6 months
Interval 3.5 to 7.4
|
—
|
3.4 months
Interval 1.8 to 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1: LAG525 1 mg/kg Q2W
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Phase 1: LAG525 3 mg/kg Q2W
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 1: LAG525 5 mg/kg Q2W
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 10 mg/kg Q2W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 15 mg/kg Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 240 mg Q2W
Serious events: 10 serious events
Other events: 24 other events
Deaths: 5 deaths
Phase 1: LAG525 400 mg Q2W
Serious events: 11 serious events
Other events: 24 other events
Deaths: 3 deaths
Phase 1: LAG525 1 mg/kg Q2W-JP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1: LAG525 240 mg Q2W-JP
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1: LAG525 400 mg Q2W-JP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 3 mg/kg Q4W
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1: LAG525 5 mg/kg Q4W
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 10 mg/kg Q4W
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Phase 1: LAG525 400 mg Q4W
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Serious events: 9 serious events
Other events: 19 other events
Deaths: 1 deaths
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Serious events: 6 serious events
Other events: 12 other events
Deaths: 2 deaths
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 13 serious events
Other events: 19 other events
Deaths: 1 deaths
Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 8 serious events
Other events: 17 other events
Deaths: 3 deaths
Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 14 serious events
Other events: 19 other events
Deaths: 2 deaths
Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 15 serious events
Other events: 41 other events
Deaths: 1 deaths
Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 9 serious events
Other events: 21 other events
Deaths: 1 deaths
Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Serious events: 10 serious events
Other events: 21 other events
Deaths: 1 deaths
Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 7 serious events
Other events: 21 other events
Deaths: 1 deaths
Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 8 serious events
Other events: 22 other events
Deaths: 1 deaths
Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 4 serious events
Other events: 16 other events
Deaths: 2 deaths
Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Serious events: 4 serious events
Other events: 14 other events
Deaths: 1 deaths
All Patients
Serious events: 208 serious events
Other events: 481 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 participants at risk
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 participants at risk
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W
n=13 participants at risk
Single-agent LAG525 1 mg/kg Q2W (ROW patients)
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 participants at risk
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 participants at risk
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 participants at risk
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 participants at risk
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=25 participants at risk
Single-agent LAG525 240 mg Q2W (ROW patients)
|
Phase 1: LAG525 400 mg Q2W
n=24 participants at risk
Single-agent LAG525 400 mg Q2W (ROW patients)
|
Phase 1: LAG525 1 mg/kg Q2W-JP
n=4 participants at risk
Single-agent LAG525 1 mg/kg Q2W (Japanese patients)
|
Phase 1: LAG525 240 mg Q2W-JP
n=5 participants at risk
Single-agent LAG525 240 mg Q2W (Japanese patients)
|
Phase 1: LAG525 400 mg Q2W-JP
n=6 participants at risk
Single-agent LAG525 400 mg Q2W (Japanese patients)
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 participants at risk
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 participants at risk
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 participants at risk
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 participants at risk
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 participants at risk
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 participants at risk
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 participants at risk
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 participants at risk
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 participants at risk
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 participants at risk
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 participants at risk
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 participants at risk
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=20 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=20 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=19 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=41 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=21 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W
n=21 participants at risk
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients with TNBC naïve to anti-PD-1/PD-L1
|
Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=22 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=22 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=19 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=16 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=14 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC pre-treated with anti-PD-1/PD-L1
|
All Patients
n=490 participants at risk
All patients
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Ileal ulcer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Malaise
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pain
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.7%
13/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Abscess
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia viral
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Troponin I increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Urine output decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Synovial sarcoma
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Product Issues
Device occlusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.1%
20/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
12/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Other adverse events
| Measure |
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
n=6 participants at risk
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
n=5 participants at risk
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W
n=13 participants at risk
Single-agent LAG525 1 mg/kg Q2W (ROW patients)
|
Phase 1: LAG525 3 mg/kg Q2W
n=12 participants at risk
Single-agent LAG525 3 mg/kg Q2W
|
Phase 1: LAG525 5 mg/kg Q2W
n=6 participants at risk
Single-agent LAG525 5 mg/kg Q2W
|
Phase 1: LAG525 10 mg/kg Q2W
n=6 participants at risk
Single-agent LAG525 10 mg/kg Q2W
|
Phase 1: LAG525 15 mg/kg Q2W
n=6 participants at risk
Single-agent LAG525 15 mg/kg Q2W
|
Phase 1: LAG525 240 mg Q2W
n=25 participants at risk
Single-agent LAG525 240 mg Q2W (ROW patients)
|
Phase 1: LAG525 400 mg Q2W
n=24 participants at risk
Single-agent LAG525 400 mg Q2W (ROW patients)
|
Phase 1: LAG525 1 mg/kg Q2W-JP
n=4 participants at risk
Single-agent LAG525 1 mg/kg Q2W (Japanese patients)
|
Phase 1: LAG525 240 mg Q2W-JP
n=5 participants at risk
Single-agent LAG525 240 mg Q2W (Japanese patients)
|
Phase 1: LAG525 400 mg Q2W-JP
n=6 participants at risk
Single-agent LAG525 400 mg Q2W (Japanese patients)
|
Phase 1: LAG525 3 mg/kg Q4W
n=5 participants at risk
Single-agent LAG525 3 mg/kg Q4W
|
Phase 1: LAG525 5 mg/kg Q4W
n=6 participants at risk
Single-agent LAG525 5 mg/kg Q4W
|
Phase 1: LAG525 10 mg/kg Q4W
n=11 participants at risk
Single-agent LAG525 10 mg/kg Q4W
|
Phase 1: LAG525 400 mg Q4W
n=5 participants at risk
Single-agent LAG525 400 mg Q4W
|
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 participants at risk
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
n=6 participants at risk
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
n=6 participants at risk
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
|
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
n=20 participants at risk
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=6 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
n=12 participants at risk
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
|
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
n=7 participants at risk
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
|
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
n=12 participants at risk
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
|
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
n=11 participants at risk
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
n=6 participants at risk
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
|
Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=20 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=20 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=19 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=41 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=21 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC naïve to anti-PD-1/PD-L1
|
Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W
n=21 participants at risk
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients with TNBC naïve to anti-PD-1/PD-L1
|
Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=22 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=22 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=19 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=16 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma pre-treated with anti-PD-1/PD-L1
|
Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W
n=14 participants at risk
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC pre-treated with anti-PD-1/PD-L1
|
All Patients
n=490 participants at risk
All patients
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.7%
13/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Chills
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
10/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Early satiety
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Extravasation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Face oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Facial pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Fatigue
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
3/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.0%
7/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
8/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
3/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
10/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
41.7%
5/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.0%
9/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.0%
4/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.6%
6/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
31.6%
6/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
8/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.4%
3/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.9%
127/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Aptyalism
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Inflammation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
6/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
2/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
3/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.6%
2/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
47.4%
9/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
6/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
92/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
External ear disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
16/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.2%
5/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
36/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Blepharitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Erythema of eyelid
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Eye oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Eye swelling
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Keratitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Lacrimal disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.9%
14/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Visual acuity reduced
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.5%
27/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
6/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
6/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
3/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.9%
68/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
24/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.7%
13/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
66.7%
4/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
6/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
35.0%
7/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
10/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
17.1%
7/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.0%
4/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.8%
102/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
5/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
10/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
6/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
66.7%
4/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.5%
8/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
5/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
4/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.6%
91/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.7%
28/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
16/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
25/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
32.0%
8/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
29.2%
7/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
45.0%
9/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
42.9%
3/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
58.3%
7/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
45.5%
5/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
30.0%
6/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
29.3%
12/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
31.8%
7/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.9%
9/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
37.5%
6/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
134/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
5/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.8%
5/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.2%
5/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
6/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
17.3%
85/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
22/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Asthenia
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
6/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.6%
2/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.0%
9/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
5/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.9%
63/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Axillary pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Catheter site erythema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Malaise
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Mucosal disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Mucosal dryness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Nodule
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.6%
6/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
29/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.6%
47/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.0%
4/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
23/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.0%
7/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.8%
5/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
17.1%
7/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
17.3%
85/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Secretion discharge
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Suprapubic pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Xerosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Erythema migrans
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.9%
14/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Otitis media
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
16/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.6%
6/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
25/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
18/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.9%
34/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
24/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.2%
40/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.0%
4/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.9%
29/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
17/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood calcium
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
26/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood prolactin abnormal
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood thyroid stimulating hormone abnormal
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Hepatitis C virus test positive
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Lipase increased
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
3/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.5%
27/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.7%
13/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Protein urine
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Thyroxine free abnormal
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Urine output decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.1%
30/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Weight increased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
White blood cell count
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
3/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
24.0%
6/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
6/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
3/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
3/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
45.0%
9/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
6/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.8%
11/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.0%
4/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
6/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
5/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
3/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
113/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
17/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.7%
18/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.1%
4/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.4%
3/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
22/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
22/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
25/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.7%
23/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
3/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.3%
31/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
4/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
4/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.7%
28/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Vitamin B1 deficiency
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.0%
4/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
35.0%
7/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.5%
8/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.6%
6/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
31.8%
7/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
4/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.0%
88/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
4/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
80.0%
4/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.6%
6/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
5/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
3/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.1%
69/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.7%
13/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
10/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.9%
14/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
4/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.1%
20/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
4/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
36/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
4/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.9%
34/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
4/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
3/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Clonus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.0%
4/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.7%
28/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
4/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.1%
15/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.8%
5/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
28.6%
2/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
6/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
3/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.4%
56/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.9%
14/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
22/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.3%
21/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Hallucination
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
6/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
2/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
2/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
36/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
10/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
1/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
10/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Breast haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Genital swelling
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
5/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.1%
20/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.8%
5/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
40.0%
2/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
66.7%
4/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.8%
11/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
3/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.0%
4/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.8%
3/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.4%
3/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.2%
94/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.2%
11/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.1%
3/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.0%
4/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
29.2%
7/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.3%
3/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
30.0%
6/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.4%
4/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.3%
5/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
17.1%
7/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
8/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.4%
3/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.4%
95/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.9%
14/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.5%
17/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.0%
2/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
10/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
16/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.5%
2/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.3%
16/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
12/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
24/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.8%
9/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
2/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
19.5%
8/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
7/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
3/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
4/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.4%
3/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.1%
64/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
2/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.3%
1/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
5/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
36.8%
7/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
4/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
5/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.8%
3/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
4/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.6%
57/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.0%
3/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
4/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.8%
4/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
23.8%
5/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.9%
34/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
3/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
2/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
2/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
2/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
24/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.3%
3/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.0%
10/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.4%
1/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.61%
3/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
3/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
2/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.2%
1/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.2%
6/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.2%
1/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Embolism
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
1/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.0%
5/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.9%
2/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.6%
8/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
1/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
1/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.8%
1/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
1/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.82%
4/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.0%
1/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
2/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
1/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.5%
2/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.4%
7/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
1/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.41%
2/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.3%
1/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/13 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/25 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/24 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/4 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/5 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/7 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/11 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
1/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/6 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/20 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/41 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/21 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/22 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/19 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/16 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/14 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.20%
1/490 • From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER